EDQM outlines ICH Q3D impurities testing guideline integration plan

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The EDQM has set out how it will integrate risk-based elemental impurities testing into the European Pharmacopoeia.

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Ocular Therapeutix has resubmitted Dextenza to US FDA after CRL

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GCP 'Renovation' paper outlines revisions to ICH E8 and E6

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SUKL finds GDP problems at B.Braun warehouse in Czech Republic

Merck's site is in Mollet des Valles, Spain. Image: Wikimedia/Rafael Ferran

Improving solubility: MilliporeSigma opens dedicated meglumine site

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Serialisation, automation and data integration: Zenith talks manufacturing in 2017

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Cipla targets South African asthma market with breath activated inhaler

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Regulatory & Safety

US FDA criticises Sato Yakuhin Kogyo Co efforts to fix data issues

US FDA criticises Sato Yakuhin Kogyo Co efforts to fix data issues

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GAO wants US FDA to show benefits of overseas inspections

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FDA calls for switching studies in draft interchangeability guidelines

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Ingredients

Chewing on a cannabis based gum to treat IBS

Medical marijuana chewing gum to treat IBS in Dutch trial

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US FDA slams Suzhou Pharmaceutical Technology for copy and paste CoAs

Aerie to build manufacturing facility in Ireland

Aerie to build manufacturing facility in Ireland

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Drug Delivery

MannKind working on an alternative to autoinjectors for epinephrine delivery. Image: iStock/smartstock

MannKind ‘aggressively’ moving forward with inhalable epinephrine

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Catalent to assess resveratrol formulation across softgel platforms

Proveca hires Quotient unit to develop more kid-friendly formulations

Proveca hires Quotient unit to develop more kid-friendly formulations

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Processing

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GEA and Siemens team on continuous processing tech

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T-ray technique faster for tablet quality and structure testing say researchers

US DEA finalises controlled substance and equipment revisions

US DEA finalises controlled substance and equipment revisions

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Popular News

Hiring and Firing Jan '17

Hiring and Firing Jan '17

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Danish regulators ban Europharma DK ApS and suggest firm needs new CEO

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Trump vows to bring drug production back to US

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